Diabetes and Risk of Diabetic Foot Ulcer
Conditions
Keywords
Diabetes, Diabetic Foot Ulcer, Plantar pressure
Brief summary
Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes. Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure are also important to take into account. The aim of the study is to assess prospectively different factors involved in DFU pathogenesis notably the neurovascular response to non noxious pressure.
Interventions
OTHERMeasure of cutaneous microcirculation
Measure of cutaneous microcirculation in response to a local application of pressure, to local heating and to the iontophoretic administration of acetylcholine
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Type 2 diabetic subject * Absence of active diabetic foot ulcer * Patients Grade 0, Grade 1, Grade 2 or Grade 3 of the International Working Group on Diabetic Foot Risk Classification defined by: * absence of alteration of perception of Monofilament 10g at the level of the plantar arch for the grade 0 * alteration of perception of Monofilament 10g at the level of the plantar arch for the grade 1 * alteration of perception of Monofilament 10g at the level of the plantar arch associated with foot deformity and / or an arteriopathy defined by the absence of perception of one of the two peripheral pulses for the grade 2 * History of diabetic foot ulcer for the grade 3 * Signature of consent to participate in the study
Exclusion criteria
* Chronic alcoholism with usual consumption of at least 5 alcoholic drinks per day * Pregnancy * Congenital methemoglobinemia. * Porphyria * Skin injured on the tibia, whatever the lesion * Recent major cardiovascular history (less than 3 months) * Severe renal disease (serum creatinine\> 300 μmol.l-1)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of incidence of diabetic foot ulcer | At any time during a 3 years follow-up | A diabetic foot ulcer is defined as a breakdown in the skin under malleolus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurovascular response to pressure | At the end of the 3-year follow-up | Receiver Operating Characteristic (ROC) analysis for neurovascular response to predict foot ulcer. Results are expressed in arbitrary unit. |
Countries
France
Contacts
Primary ContactJulien Vouillarmet
Outcome results
None listed